CY5 Clinical Trials

Size	Price	Qty
5mg	USD 197

Clinical Trials

A clinical trial sponsored by Memorial Sloan Kettering Cancer Center is evaluating CY5-containing diagnostic imaging agents via microdosing with targeted ultrasmall silica particle tracers. This early-phase study investigates tracer uptake and diagnostic imaging performance in patients with brain cancer and pituitary adenoma. Currently active, not recruiting, the trial represents the initial clinical evaluation of CY5-tagged nanoparticles in neuro-oncological diagnostics.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03465618	ACTIVE_NOT_RECRUITING	Brain Cancer; Pituitary Adenoma	Memorial Sloan Kettering Cancer Center	2018-03-07	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-01)

Check the CY5 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cy5 acts as a far-red fluorescent dye that covalently conjugates to molecular targeting ligands or silica particle platforms, producing a distinct emission at 670 nm upon 649 nm excitation. This spectrally efficient fluorescence emission enables high-contrast optical tracking of tagged bioconjugates, providing crucial diagnostic visualization for intraoperative surgical guidance and lesion detection in brain cancer and pituitary adenoma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).